Senior Clinical Data Manager at Pharmaceutical Company in Boston, Massachusetts, United States —
- Pharmaceutical Company
- Boston, Massachusetts, United States USA
- 5/14/19 2019-05-14
Job ID: 335608
-Manage clinical study data or data management projects under aggressive timelines in a high quality and professional manner.
-Review protocols and identifies requirements for proper data capture including electronic Case Report Form design and processing of clinical data ensuring accuracy, consistency and completeness while adhering to SOPs and work guidelines as required.
-Designs or reviews creation and maintenance of all essential data management documentation including CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans (detailing complete data management processes throughout clinical studies), Data Review Guidelines, Data Entry Guidelines, Data Transfer specifications and laboratory data handling.
-Responsible for review of medical coding, block cleaning, database lock and freeze, and SAE reconciliation activities performed by external vendors.
-Review and approve all DM documentation; maintain all data management internal files, ensuring preparedness for regulatory inspections.
-Functional representative on project teams, study teams, development teams including multi-disciplinary interactions by participating in/leading project meetings to ensure clear overview of progress, risks and mitigation strategies by all participants for all data management related deliverables.
-Must have CRO/Vendor oversight experience
-At least 4-7 years in Data Management for the pharmaceutical/biotechnology industry.
-Ability to be primary DM representative with little oversight required.